Common use of Research and Development Activities Clause in Contracts

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED ]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2. (b) During the Exclusive Period, ICN shall assist Schering from time to time, at Schering's reasonable request, in the design and implementation of clinical studies, if Schering chooses, to undertake such studies for a CPMP Opinion or Regulatory Approval for the chronic hepatitis C indication for the Product. ICN shall assist Schering at Schering's reasonable request, in the identification of clinical study sites in the Territory, the recruitment of investigators, the review of study protocols and the monitoring of the clinical studies (to the extent feasible in conjunction with ICN's own scheduled monitoring for studies related to its other products, without the need for additional resources). Schering shall reimburse ICN for its reasonable out-of-pocket costs and expenses (equitably prorated, if applicable, for monitoring expenses) incurred in rendering such assistance, unless otherwise agreed by ICN. ICN shall invoice Schering for such expenses, and, upon request, shall provide documentation for the invoice. The invoice shall be payable to ICN or its designee(s) thirty (30) days after receipt by Schering of the invoice. (c) During the Exclusive Period, Schering shall be responsible for any quality of life, cost-benefit, cost-effectiveness, pharmacoeconomic and any other studies (or portions of studies) necessary or desirable for pricing and reimbursement approvals in the Territory, as well as any pre-marketing studies prior to Regulatory Approval and post-marketing studies conducted following a Regulatory Approval. ICN shall assist Schering from time to time, at Schering's reasonable request, with incidental support in the conduct of the studies. (d) All data obtained by Schering or ICN which is reasonably available to be reported from any activities conducted under Section 3.1(a), (b) or (c) shall be jointly owned by the Parties, and Schering and ICN shall each have the right to use all such data for all purposes contemplated or permitted by this Agreement. Notwithstanding such joint ownership, any such data shall be subject to the publication procedures set forth in Exhibit F. ICN will use its reasonable efforts to apply such procedures to any studies that commenced prior to and are planned as of the Effective Date. (e) Schering shall have the right to use for all purposes in connection with obtaining Regulatory Approval for the Product in the Territory for the treatment of chronic hepatitis C, all existing data relating thereto owned, controlled or in the possession of ICN as of the Effective Date.

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED [REDACTED]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2. (b) During the Exclusive Period, ICN shall assist Schering from time to time, at Schering's reasonable request, in the design and implementation of clinical studies, if Schering chooses, to undertake such studies for a CPMP Opinion or Regulatory Approval for the chronic hepatitis C indication for the Product. ICN shall assist Schering at Schering's reasonable request, in the identification of clinical study sites in the Territory, the recruitment of investigators, the review of study protocols and the monitoring of the clinical studies (to the extent feasible in conjunction with ICN's own scheduled monitoring for studies related to its other products, without the need for additional resources). Schering shall reimburse ICN for its reasonable out-of-pocket costs and expenses (equitably prorated, if applicable, for monitoring expenses) incurred in rendering such assistance, unless otherwise agreed by ICN. ICN shall invoice Schering for such expenses, and, upon request, shall provide documentation for the invoice. The invoice shall be payable to ICN or its designee(s) thirty (30) days after receipt by Schering of the invoice. (c) During the Exclusive Period, Schering shall be responsible for any quality of life, cost-benefit, cost-effectiveness, pharmacoeconomic and any other studies (or portions of studies) necessary or desirable for pricing and reimbursement approvals in the Territory, as well as any pre-marketing studies prior to Regulatory Approval and post-marketing studies conducted following a Regulatory Approval. ICN shall assist Schering from time to time, at Schering's reasonable request, with incidental support in the conduct of the studies. (d) All data obtained by Schering or ICN which is reasonably available to be reported from any activities conducted under Section 3.1(a), (b) or (c) shall be jointly owned by the Parties, and Schering and ICN shall each have the right to use all such data for all purposes contemplated or permitted by this Agreement. Notwithstanding such joint ownership, any such data shall be subject to the publication procedures set forth in Exhibit F. ICN will use its reasonable efforts to apply such procedures to any studies that commenced prior to and are planned as of the Effective Date. (e) Schering shall have the right to use for all purposes in connection with obtaining Regulatory Approval for the Product in the Territory for the treatment of chronic hepatitis C, all existing data relating thereto owned, controlled or in the possession of ICN as of the Effective Date. (f) The Parties recognize that ICN's development studies with respect to other indications of the Product should not interfere with the development activities conducted by Schering with respect to the chronic hepatitis C indication. Accordingly: (i) ICN shall promptly disclose to Schering all studies in progress and planned as of the Effective Date relating to the Product in connection with any hepatitis indications; (ii) If Schering determines in its reasonable business judgment that the continuation of any such studies by ICN would significantly interfere with Schering's studies with respect to chronic hepatitis C, Schering may require ICN to postpone such studies for so long as is necessary such that ICN's continuation of its studies would not interfere with Schering's studies, but such postponement shall not be more than [REDACTED]; (iii) If after the Effective Date ICN wishes to commence a clinical development program for the Product for a hepatitis indication other than the chronic hepatitis C indication, then ICN shall consult with Schering with respect to the possible joint development of such indication. If Schering declines or does not agree within 30 days to participate in such a joint development program, then ICN shall be free to continue such development. If Schering determines in its reasonable business judgment that the continuation of any such studies by ICN would significantly interfere with Schering's studies with respect to chronic hepatitis C, Schering may require ICN to postpone such studies for so long as is necessary such that ICN's continuation of its studies would not interfere with Schering's studies, but such postponement shall not be more than [REDACTED].

Research and Development Activities. (a) Following the Effective Date, Schering or its Affiliates shall assume and incur all costs and expenses in connection with the research and development activities which in its sole judgment are necessary to obtain any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. ICN shall supply Schering with all of its requirements of Product for such research and development activities in finished bulk capsules, and bulk substance as necessary for preclinical studies, [ REDACTED ]. During the Exclusive Period, Schering shall also be responsible, at its cost and expense, for all preclinical studies, pre-marketing and compassionate use programs, clinical trials, chemistry/pharmacy data, any post approval studies required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory, and any other information and data required as a condition of obtaining any CPMP Opinion or Regulatory Approval for the Product for the chronic hepatitis C indication in the Territory. The studies which Schering intends to undertake, together with preliminary timetables and preliminary budgets, are set forth in Exhibit D attached hereto and incorporated herein by reference. Schering shall commence, within 45 days [REDACTED ] after the Effective Date, the activities necessary to obtain Regulatory Approval in the EU, and shall diligently pursue and conduct such activities as may be necessary in order to obtain regulatory Approval for the Product for the chronic hepatitis C indication in each country in the Territory, in accordance with Section 3.2. (b) During the Exclusive Period, ICN shall assist Schering from time to time, at Schering's reasonable request, in the design and implementation of clinical studies, if Schering chooses, to undertake such studies for a CPMP Opinion or Regulatory Approval for the chronic hepatitis C indication for the Product. ICN shall assist Schering at Schering's reasonable request, in the identification of clinical study sites in the Territory, the recruitment of investigators, the review of study protocols and the monitoring of the clinical studies (to the extent feasible in conjunction with ICN's own scheduled monitoring for studies related to its other products, without the need for additional resources). Schering shall reimburse ICN for its reasonable out-of-pocket costs and expenses (equitably prorated, if applicable, for monitoring expenses) incurred in rendering such assistance, unless otherwise agreed by ICN. ICN shall invoice Schering for such expenses, and, upon request, shall provide documentation for the invoice. The invoice shall be payable to ICN or its designee(s) thirty (30) days after receipt by Schering of the invoice. (c) During the Exclusive Period, Schering shall be responsible for any quality of life, cost-benefit, cost-effectiveness, pharmacoeconomic and any other studies (or portions of studies) necessary or desirable for pricing and reimbursement approvals in the Territory, as well as any pre-marketing studies prior to Regulatory Approval and post-marketing studies conducted following a Regulatory Approval. ICN shall assist Schering from time to time, at Schering's reasonable request, with incidental support in the conduct of the studies. (d) All data obtained by Schering or ICN which is reasonably available to be reported from any activities conducted under Section 3.1(a), (b) or (c) shall be jointly owned by the Parties, and Schering and ICN shall each have the right to use all such data for all purposes contemplated or permitted by this Agreement. Notwithstanding such joint ownership, any such data shall be subject to the publication procedures set forth in Exhibit F. ICN will use its reasonable efforts to apply such procedures to any studies that commenced prior to and are planned as of the Effective Date. (e) Schering shall have the right to use for all purposes in connection with obtaining Regulatory Approval for the Product in the Territory for the treatment of chronic hepatitis C, all existing data relating thereto owned, controlled or in the possession of ICN as of the Effective Date.